Brainlab recalls specific DrapeLink Adapters for spine/trauma 3D systems due to manufacturing error. Affected units have unique serial numbers and model numbers. No remedy stated in recall notice.
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
Brainlab is recalling certain DrapeLink Adapters for their Spine & Trauma 3D navigation systems because they were not made correctly due to a supplier error. This could lead to improper function during medical procedures, but the recall does not include a fix or return process.
The adapters were not manufactured to specifications due to a supplier error, which could cause improper alignment during medical procedures. This might lead to inaccurate imaging or treatment outcomes, though the exact risk level isn't specified in the recall.
Medical professionals using Brainlab's Spine & Trauma 3D systems with the specific DrapeLink Adapters mentioned in the serial numbers are likely affected. Patients receiving these procedures may be at risk if the adapters malfunction.
Check for serial numbers between 7459316001-7459316027 or 7714816001-7714816017. Look for model numbers 19154 or 19154-04 with the specified UDI GTIN codes.
Verify if your adapter has a serial number in the range 7459316001-7459316027 or 7714816001-7714816017.
Due to a supplier error, an unknown number of adapters were not manufactured to specifications.
Check for serial numbers in the range 7459316001-7459316027 or 7714816001-7714816017, or model numbers 19154 or 19154-04.
The recall notice does not specify a remedy, so no action is required beyond checking if your adapter is affected.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0320-2018 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-0320-2018 from Brainlab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
